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It was reported that during insertion in the nsicu, resistance was met when inserting the guide wire.
As a result, the guide wire was removed and found kinked.
A new kit was opened and used without issue.
A delay was reported, however, there was no additional harm to the patient due to this delay or as a result of this occurrence.
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Qn#(b)(4).
Device evaluation: the reported complaint of the guide wire became kinked during insertion was confirmed.
The customer returned one guide wire.
Visual examination of the guide wire revealed four kinks at the distal end of the wire and the j- bend appeared typical.
The four kinks were measured at 1.
3, 1.
9, 2.
1 and 2.
8 cm from the distal weld.
Microscopic examination confirmed the four kinks and found that three kinks had offset coils.
Microscopic examination also confirmed that both welds were full and spherical.
A manual tug test confirmed that both welds remain intact.
The guide wire measured approximately 601 mm in the total length and exhibited an outside diameter (od) measured 0.
804 mm.
The returned guide wire was within specification for length and od per guide wire graphic (length: 596 - 604 mm and od: 0.
788- 0.
826mm).
The instructions for use, describe suggested techniques to minimize the likelihood of guide wire damage during use.
The device history record review was performed and did not reveal any manufacturing related issues.
Since the guide wire is always inserted through another component such as an introducer needle, ars syringe, or introducer catheter and none other remarks: of these components were returned, the probable cause of this issue could not be determined.
No further action will be taken.
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